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Public Citizen Petitions FDA for Black Box Warning on Plavix

Aug 22, 2013

A leading advocacy group petitioned federal health regulators to issue a stronger warning regarding potential fatal risks associated with the blood-thinning drug Plavix.

Public Citizen says that the U.S. Food and Drug Administration (FDA) should add its strongest “black box” warning to safety labels of Plavix (clopidogrel) to indicate a risk of fatal bleeding episodes exists if certain patients ingest the drug; namely, those who have had a drug-eluting artery stent implanted to correct a blockage. These patients should be warned to not take Plavix for more than a year after this treatment.

If Plavix is taken within a year of such treatment, the patient could experience a fatal bleeding episode.

Patients often receive one of these stents after suffering a heart attack, according to a release from Public Citizen, which called upon the FDA via petition this week to add its strongest warning possible to Plavix safety labels. The advocacy group said there is enough clinical evidence available about the risks of Plavix for people with an implanted drug-eluting stent to support their petition.

“The research shows that using this drug for more than 12 months puts people at risk of potentially life-threatening bleeding, without any evidence that it’s doing any good at that point,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group. “The FDA should promptly warn against prolonged use on the product’s labeling, require a warning in patient medication guides, and ask the manufacturers to send a letter warning physicians.”

Based on our previous reports, there is clinical evidence that shows people who take Plavix face a higher risk of severe bleeding episodes, including incidents of cerebral and gastrointestinal hemorrhaging. Other studies we’ve noted show that people taking Plavix also face a higher risk of Thrombotic Thrombocytopenic Purpura (TTP). Many bleeding episodes linked to Plavix patients are life-threatening.

In fact, one study appearing in the New England Journal of Medicine revealed that patients on Plavix were 12 times more likely to suffer from ulcers, as well as abdominal and cerebral bleeding. Another study conducted by the U.S. Centers for Disease Control and Prevention (CDC) showed that the risk of severe bleeding among patients taking Plavix instead of aspirin and a heartburn drug was much higher than previously believed, according to our reports.

Public Citizen says that its Plavix warning will reach a large audience. There were more than 25 million prescriptions written for Plavix or its generic form in the past year, the organization says.

The group suggests the following should be added to Plavix’s label: “The continuation of clopidogrel for longer than 12 months following percutaneous insertion of a drug-eluting stent is of questionable additional benefit in preventing adverse cardiac events but continues to carry an increased risk of major and minor bleeding, even in those who have no known bleeding tendency.”

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